BCIwiki (bciwiki.com) — According to study information from Cognixion, a study comparing a wearable brain-computer interface (BCI) communication device with eye-tracking devices already used by people with amyotrophic lateral sclerosis (ALS) has been registered on ClinicalTrials.gov as NCT07871071. The record was first submitted on 2026-10-07, and both its first posting and latest update were on 2026-10-13. The study is not yet recruiting and has an estimated start date of 2026-11-15.
The study plans to enroll 30 adults with ALS who currently use a Tobii Dynavox or Smartbox eye-tracking device. Each participant will use three communication options at home over 12 weeks: their own eye-tracking device, Cognixion ONE with a head-worn augmented-reality display, and Cognixion ONE with a screen-based display. Some sessions will assign an option; others will allow participants to choose.
Cognixion explains that people who lose speech as ALS progresses may rely on eye-tracking speech-generating devices, but reliability can decline when oculomotor control is affected. The company says Cognixion ONE adds BCI input that does not depend on eye movement, alongside an AI-assisted communication application. These statements describe the device design and study rationale, not benefits demonstrated by this study.
The primary measure is the time participants voluntarily choose to spend using each option. The study treats this choice as a key indication of which option works better for the individual. It will also measure communication speed and accuracy, usability, workload, quality of life, and caregiver burden. Estimated primary completion is 2028-04, and estimated overall completion is 2029-06. No results have been posted. Cognixion ONE is an investigational research device and is not approved or cleared by the FDA for any medical use.